Quality Assurance Associate

Description

Who Are We?

Biolog is a leader in microbial identification, phenotypic cell profiling, and metabolic fingerprinting for microbial and mammalian cells. The main office is located in Hayward, CA, the company’s products enable the identification of thousands of species of bacteria, yeast, and fungi as well as characterization of human cells and mitochondria. Our second office is located in Delaware; MIDI Labs, an innovator in microbial identification, currently offers contract laboratory services for microbial identification and enumeration to deliver critical, time-sensitive ID for pharmaceutical, probiotic, food and beverage, and personal care manufacturing operations using sequencing and MALDI-TOF mass spectrometry. Biolog products are available worldwide, either directly from the company or through its extensive network of international distributors.

What Do We Value?

We are passionate about all the ways our technology can impact R&D and industrial applications including microbial characterization and identification, synthetic biology, biomanufacturing, bioprocess development, metabolic and mitochondrial disorders, nutrition, toxicology, and drug discovery.

What We Offer:

· Competitive Compensation Packages (Base plus commission structure)

· Car Allowance plus mileage

· Annual Bonus Plan

· 100% employee/ 75 % dependent Medical, Dental and Vision premiums are paid for by

the company

· Company provided life insurance plan

· 401k Plan

· Stock Options

Additional Information:

The role is on-site at our Newark, DE location.

Requirements

What is the Job all About?

· QA Associate

· Newark, DE

The Quality Associate is responsible for technical and logistic aspects of sample processing, maintaining/manufacturing consumables, reagents, media, and quality activities.

The role will most influence the successful delivery of high-quality results and customer satisfaction by:

Ensuring Effective Quality Assurance to Meet Customer Expectations:

• Manages time and resources efficiently to ensure that all testing and quality processes meet key turn-around times and customer requirements.
• Strictly adheres to safety protocols for laboratory operations, including handling and disposal of chemical and biohazardous waste.
• Implements and follows Quality System Procedures (QSP) to ensure that all services meet regulatory standards and customer requests.
• Reviews and approves incoming and outgoing Certificates of Analysis (CofAs) to ensure accurate and timely customer release.
• Collaborates with the lab team to continuously improve processes, aiming to enhance service delivery and efficiency.
• Maintains open and transparent communication with the Quality Manager and Laboratory Management to address any quality-related issues promptly.

Adhering to Regulatory and Accreditor Requirements:

• Ensures full compliance with cGMP and ISO 17025:2017 standards in every aspect of the lab’s operations, with a specific focus on quality assurance.
• Helps monitor and improve the lab's adherence to all relevant regulations, maintaining the highest standards of quality in both testing and customer relations.
• Assists with maintaining and keeping accreditations with ISO, USDA, FDA, and GDUFA, ensuring continued regulatory compliance and high standards of operation.

Supporting the Quality Manager in Overseeing the Quality System:

• Actively participates in quality planning, equipment qualification, process validation, audits, risk assessments, and implementation of corrective actions to ensure continuous improvement of the Quality Management System (QMS).
• Assists in developing, reviewing, and updating key Quality System documentation, including the Quality Manual, Quality Forms, and Standard Operating Procedures (SOPs).
• Supports the monitoring and resolution of issues reported in the CAPA system, ensuring that any corrective actions are implemented and documented properly.
• Assists with both internal and external audits, acting as a liaison for Customers during any quality-related inquiries or events.

Enhancing Customer Satisfaction:

• Engages proactively with customers to address quality issues, ensuring quick resolutions that meet customer expectations.
• Serves as the primary point of contact for quality-related customer inquiries and events, fostering positive relationships through professional representation of the company's values and ethics.
• Works collaboratively with the team to ensure that customer agreements and quality questionnaires are completed accurately and efficiently, helping maintain strong client trust and satisfaction.

Continuous Improvement and Customer Support:

• Actively contributes to customer-facing activities, promoting the company’s commitment to quality and customer service.
• Supports all aspects of customer satisfaction by assisting with customer sample processing, ensuring accurate and timely invoicing, and representing the company’s high standards of quality.

This role plays a critical part in upholding Biolog Lab Services' reputation for excellence in quality and customer satisfaction.

• Bachelor’s degree in life science or a related field
• Strong understanding of Quality Assurance principles with experience ensuring compliance with customer expectations and regulatory standards
• Experience approving Certificates of Analysis (CofAs) for customer release
• Proficient in computer skills – including Microsoft Office Suite, Laboratory Information Management Systems (LIMS)
• Ability to follow SOPs and other protocols precisely, with attention to detail in process documentation and reporting
• Familiarity with ISO 17025, cGMP/GLP, 21 CFR part 211, and other regulatory lab practices (USDA, FDA, GDUFA) to ensure compliance and accreditation maintenance
• Experience in a Quality role within a regulated lab service, pharmaceutical, or technology company, with a focus on customer satisfaction and regulatory compliance
• Experience implementing and maintaining a Quality Management System, including document control, process validation, and risk management
• Experience training personnel on Quality Management Systems, regulatory requirements, and quality protocols
• Experience with internal and external audits, including preparation, participation, and post-audit corrective actions
• Isolocity QMS software or similar is a plus

Job Type: Full-time

Pay: $55,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• Quality management: 2 years (Required)
• ISO 17025: 1 year (Required)
• FDA regulations: 1 year (Preferred)
• CGMP: 1 year (Required)

Ability to Commute:

• Newark, DE 19702 (Required)

Ability to Relocate:

• Newark, DE 19702: Relocate before starting work (Required)

Work Location: In person

Salary : $55,000 - $65,000